QRxPharma to file NDA within two months

QRxPharma (ASX: QRX) is nearing the final hurdle in bringing its dual-opioid pain drug, MoxDuo, to market, with the company planning to file a New Drug Application (NDA) with the US Food and Drug Administration within the next two months.

MoxDuo IR capsules are a patented 3:2 fixed ratio combination of morphine and oxycodone that targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.

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The company just completed a phase III study looking at the safety and tolerability of MoxDuo compared with equally pain-relieving doses of either morphine or oxycodone alone.

The trial found significantly shorter and less severe periods of respiratory depression when treated with MoxDuo IR, compared to morphine or oxycodone.

Episodes of respiratory depression are a commonly reported and expected side effect associated with use of opioid analgesics. Such events are clinically measured by changes in blood oxygenation (pulse oximetry –SpO₂).

In this study, measures of insufficient blood oxygenation (oxygen desaturation SpO₂<90%) over time to assess both the severity and duration of respiratory impairment indicated that MoxDuo has a significantly better (p<0.02) safety profile than oxycodone. Beneficial trends for MoxDuo also occurred in comparisons to morphine treatment on these same endpoints. In addition, the secondary endpoints of opioid related side effects were consistent with previous studies demonstrating that the occurrence of moderate to severe vomiting was significantly (p<0.04) reduced (32% vs. 42%) in MoxDuo IR treated subjects compared to patients receiving oxycodone alone at the same 24 mg morphine equivalent dose.

Morphine and MoxDuo had comparable rates of moderate-severe vomiting. In respect to nausea, the overall incidence of this treatment emergent adverse event trended lower in the MoxDuo treated subjects than oxycodone and morphine, but the differences were not statistically significant.

The company has announced the trial results will form part of the NDA to be filed with the US FDA within two months time.

QRxPharma (ASX:QRX) shares at $1.84 at midday, level through morning trading, although they’ve dropped over 7.5% since Wednesday last week.